PURE Laser, System ND_PRD00456-00

GUDID 07290016814361

The PURE Laser system is a non-invasive laser based system used for Hair Removal

ENDYMED MEDICAL LTD

Dermatological diode laser system
Primary Device ID07290016814361
NIH Device Record Keyf8b58040-1aca-420b-bb40-20119e389695
Commercial Distribution StatusIn Commercial Distribution
Brand NamePURE Laser, System
Version Model NumberPURE Laser
Catalog NumberND_PRD00456-00
Company DUNS531958689
Company NameENDYMED MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016814361 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-27
Device Publish Date2023-06-19

Devices Manufactured by ENDYMED MEDICAL LTD

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07290016814415 - endyMed PRO MAX, Intensif MAX Handpiece2024-05-24 The Intensif applicator is intended for use in dermatologic and general surgical procedure for electrocoagulation nd hemostasis
07290016814422 - EndyMed PRO MAX, Small MAX Handpiece2024-05-24 The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic
07290016814439 - EndyMed PRO MAX, FSR MAX Handpiece2024-05-24 The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic
07290016814446 - EndyMed PRO MAX, iFine MAX Handpiece2024-05-24 The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic
07290016814453 - EndyMed PRO MAX,Shaper MAX Handpiece2024-05-24 The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic
07290016814460 - EndyMed PRO MAX,Mini Shaper MAX Handpiece2024-05-24 The handpiece is used as an accessory to EndyMed PRO MAX system, which is a noninvasive device intended for use in Dermatologi
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